Regulatory


Topic Replies Activity
Same product can be manufacturer at both location 5 May 25, 2018
Bioavailability of Injectables 4 May 25, 2018
Manufacturing License approval on the basis of marketed similar product 1 May 13, 2018
Extractable and Leachable study in Dry powder injection in Glass vails type -1 1 May 12, 2018
API In House Specification 5 May 10, 2018
Difference between BA BE & Clinical Trials 2 April 20, 2018
Packaging material 1 April 5, 2018
Dry syrup container 1 April 5, 2018
Package leaflet 1 March 10, 2018
List of submted ANDAs in USFDA 2 March 5, 2018
GMP Facility for multiple product 2 February 23, 2018
Indian Regulatory - Suppose unapproved drug in India for marketing & manufacturering 4 February 1, 2018
Regulatory 0 January 28, 2018
Type 1A variation 1 November 21, 2017
Product Development Report 1 November 2, 2017
Claim of the finished prodct 2 November 1, 2017
IT Policy 2017 in Pharma Sector 1 September 25, 2017
Certificate of Analysis in GDP 4 September 1, 2017
COPP /dossier submission 1 August 5, 2017
Pharma HSN COde 1 June 28, 2017
Difference between DMF and 32S 2 June 3, 2017
Packaging cartons 4 June 3, 2017
DMF and Dossier 3 June 3, 2017
Can we manufacure bacteria as well as yeast in same facility 1 June 1, 2017
Discolouration of tablets containing Paracetamol and Codeine Phosphate as APIs 2 April 30, 2017
Celecoxib capsules - biowaiver 1 February 1, 2017
Procedure to obtain Drug License 1 December 16, 2016
Innovator characterization 3 December 14, 2016
Difference between guideline used in pharmaceuticals 2 December 12, 2016
If manufactured have get DCGI permission then manufactured can be export the product without local FDA permission 1 November 29, 2016
 

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